hepatocellular carcinoma
Conditions
Interventions
Apatinib:Apatinib po.
Control group:None
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old; 2. Hepatocellular carcinoma was clinically or pathologically confirmed, and the clinical diagnosis of hepatocellular carcinoma was in accordance with the AASLD standard; 3. Surgical treatment was received, and postoperative pathology confirmed that the R0 resection standard was reached; 4. Postoperative recurrence and complete tumor necrosis were confirmed by reexamination 4-6 weeks after local ablation (CR, assessed according to mRECIST standard); 5. The tumor should meet at least one of the following high-risk conditions before ablation: (1) 2 to 3 tumors; (2) The nearest place of tumor to portal vein or hepatic vein trunk or primary branch =1.5x10^9/L; Platelet >=80x10^9/L; Hemoglobin >=90 g/L; Serum albumin >=30 g/L; Thyroid stimulating hormone (TSH)<=1 ULN (IF abnormal, FT3 and FT4 levels should be measured at the same time; if NORMAL, FT3 and FT4 levels can be included); Bilirubin <=1.5 ULN (within 7 days before the first administration); ALT and AST <=3 ULN (within 7 days before the first medication); PT longer than ULN by no more than 3 seconds; Serum creatinine <=1.5 ULN; 11. Patients volunteered to participate in the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Received systematic treatment in the past; 2. Received other anticancer treatments (including radiotherapy, vascular intervention, etc.) except hepatocellular carcinoma resection and ablation therapy; 3. Patients with known history of central nervous system metastasis or hepatic encephalopathy; 4. Reexamination of imaging findings could not determine the completely malignant tumor death after local ablation; 5. Ascites with clinical symptoms, requiring puncture and drainage or having received ascites drainage in the past 3 months, except for those with imaging findings showing a small amount of ascites but no clinical symptoms; 6. Having hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure >=140mmHg or diastolic blood pressure >=90mmhg); 7. Clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure of NYHA2 or above; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; (5) QTc>450ms (male);QTc>470ms (female); 8. Abnormal coagulation function (INR>2.0, PT>16s), bleeding tendency or receiving thrombolytic therapy or anticoagulant therapy, prophylactically permitted to use low-dose aspirin and low-molecular heparin; 9. Random before 3 months there have been significant clinical significance of bleeding symptoms or have a definite bleeding tendency, such as daily cough/haemoptysis 2.5 ml and above, gastrointestinal bleeding, there is a risk of bleeding of esophageal gastric varices, hemorrhagic peptic ulcers, or patients with vasculitis, baseline period if defecate occult blood positive, to review, after review if still positive, the need for gastroscopy, if gastroscope prompt severe feed tube gastric varices is not into the group (the group within the first 3 months and accept gastroscopy except of ruled out such a situation); 10. Randomly occurring ARTERIAL/venous thrombosis events, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, within the first 6 months; 11. Genetic or acquired bleeding and thrombotic tendencies known to exist (e.g., hemophilia, coagulation disorders, thrombocytopenia, etc.); 12. Urine routine indicated urinary protein = ++ and confirmed 24-hour urinary protein amount > 1.0g; 13. Previously received radiotherapy, chemotherapy, hormone therapy, surgery and other anticancer therapies; 14. The patient had active infection, unexplained fever =38.5? within 7 days before medication, or white blood cell count >15x10^9/L at baseline; 15. Patients with congenital or acquired immune deficiency (e.g., HIV-infected).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 years RFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Safety assessment; | — |
Countries
China
Contacts
Public ContactZhang Lan
Zhongshan Hospital, Fudan University
Outcome results
None listed